[Federal Register Volume 60, Number 118 (Tuesday, June 20, 1995)]
[Proposed Rules]
[Pages 32128-32129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15084]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1270

[Docket No. 93N-0453]


Screening and Testing of Donors of Human Tissue Intended for 
Transplantation; Draft Document; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Screening and Testing of 
Donors of Human Tissue Intended for Transplantation.'' This draft 
document is intended to provide additional opportunity for individuals 
to submit comments on screening and testing of donors of human tissue 
for transplantation. The availability of the draft document is to 
coincide with the workshop on Human Tissue for Transplantation and 
Human Reproductive Tissue: Scientific and Regulatory Issues and 
Perspectives to be held June 20 and 21, 1995, in Bethesda, MD. The 
workshop was announced in the Federal Register of May 24, 1995.

DATES: Written comments on the draft document should be submitted by 
July 20, 1995.

ADDRESSES: Single copies of the draft document will be made available 
to those attending the workshop. Persons not attending the workshop who 
would like to receive a copy of the draft document should submit a 
written request for single copies to the Congressional and Consumer 
Affairs Branch (HFM-12), Food and Drug Administration, 1401 Rockville 
Pike, suite 200 North, Rockville, MD 20852-1448. Send two self-
addressed adhesive labels to assist that office in processing your 
requests.-
     Persons with access to the INTERNET may request the draft document 
be sent by return E-mail by sending a message to 
``[email protected]''. The draft document may also be obtained 
through INTERNET via File Transfer Protocol (FTP). Requestors should 
connect to the Center for Drug Evaluation and Research (CDER) using the 
FTP. The Center for Biologics Evaluation and Research (CBER) documents 
are maintained in a subdirectory called CBER on the server, 
``CDV2.CBER.FDA.GOV''. The ``READ.ME'' file in that subdirectory 
describes the available documents, [[Page 32129]] which may be 
available as an ASCII text file (*.TXT), or a WordPerfect 5.1 document 
(*.w51), or both. A sample dialogue for obtaining the READ.ME file with 
a test based FTP program would be:
FTP CDV2.CBER.FDA.GOV
LOGIN ANONYMOUS

BINARY
CD CBER
GET READ.ME
EXIT
The draft document may also be obtained by calling the CBER FAX 
Information System (FAX-ON-DEMAND) at 301-594-1939 from a FAX machine 
with a touch tone phone attached or built-in.
     Submit written comments on the draft document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Two copies of any comments are 
to be submitted, except that individuals may submit one copy. Requests 
and comments should be identified with the docket number found in 
brackets in the heading of this document. The draft document and 
received comments are available for public examination in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Martha A. Wells, Center for Biologics 
Evaluation and Research (HFM-305), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-0967.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 24, 1995 (60 
FR 27406), FDA published a notice announcing a public workshop on Human 
Tissue for Transplantation and Human Reproductive Tissue: Scientific 
and Regulatory Issues and Perspectives to be held on June 20 and 21, 
1995, from 8:30 a.m. to 5:30 p.m., at the National Institutes of 
Health, Bldg. 45, Natcher Auditorium, 9000 Rockville Pike, Bethesda, 
MD. The purpose of the workshop is to provide an opportunity for 
continued discussion of FDA's interim rule on human tissue for 
transplantation published in the Federal Register of December 14, 1993 
(58 FR 65514). The workshop will include discussions of other related 
issues, including possible regulation of reproductive tissue. The 
notice stated that one of the objectives of the public workshop is to 
provide an opportunity for discussion of current screening and testing 
practices for donors of human tissue for transplantation and human 
reproductive tissue.
    The draft document, developed by a task force composed of FDA staff 
from CBER, is designed to focus discussion towards specific points on 
testing and screening donors of human tissue intended for 
transplantation. The document includes the following topics: Required 
donor testing, donor suitability and screening test performance, plasma 
dilution, testing algorithm, sources of information for donor 
screening, behavioral risk information, clinical evidence of human 
immunodeficiency virus and hepatitis, and suitable autopsy.
    Copies of the draft document will be available at the workshop. A 
copy of the draft document will be placed on file with the Dockets 
Management Branch (address above) under the docket number found in 
brackets in the heading of this notice. To accommodate interested 
persons who do not attend the workshop, as well as those who will be 
attending the workshop, FDA is making the draft document available for 
public comment and will consider such comments in any future rulemaking 
and in the development of regulatory policies. Comments should be 
submitted to the Dockets Management Branch (address above) by July 20, 
1995.
    FDA does not intend this draft document to be all-inclusive. This 
document does not bind FDA and does not create or confer any rights, 
privileges, or benefits on or for any private person, but is intended 
merely for discussion.

    Dated: June 14, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-15084 Filed 6-15-95; 4:43 pm]
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